Okumura Yuichiro, Noda Takehiro, Eguchi Hidetoshi, Iwagami Yoshifumi, Yamada Daisaku, Asaoka Tadafumi, Wada Hiroshi, Kawamoto Koichi, Gotoh Kunihito, Takeda Yutaka, Tanemura Masahiro, Marubashi Shigeru, Umeshita Koji, Doki Yuichiro, Mori Masaki
Department of Gastroenterological Surgery, Graduate School of Medicine, Osaka University, Osaka, Japan.
Department of Surgery, Kansai Rosai Hospital, Hyogo, Japan.
Transplant Direct. 2017 Aug 23;3(9):e207. doi: 10.1097/TXD.0000000000000722. eCollection 2017 Sep.
Tacrolimus is the key immunosuppressive drug for liver transplantation. Once-daily prolonged-release tacrolimus (TAC-PR) exhibits good drug adherence but has difficulty controlling the trough level in the early phase of liver transplantation. The aim of this study was to compare the feasibility and efficacy of immediately starting oral TAC-PR versus traditional twice-daily tacrolimus (TAC-BID) in de novo liver transplantation recipients.
The study included 28 patients treated with conventional TAC-BID and 60 patients treated with TAC-PR (median follow-up 70.5 months). Short-term and long-term outcomes were compared.
Patient characteristics were similar except for the incidence of hepatocellular carcinoma and type of graft. Dose adjustment was more frequently required for TAC-PR than TAC-BID (73.3% vs 42.9%, = 0.006), but trough levels of TAC during the first 3 months after liver transplantation were controlled well in both groups. The rate of acute cellular rejection and long-term renal function were similar in both groups. In both groups, renal function worsened during the first 6 months after transplantation and remained stable until the end of the follow-up period. The 1-year, 3-year, and 5-year survival rates were 96.4%, 85.7%, and 85.7% for TAC-BID and 96.7%, 94.8%, and 94.8% for TAC-PR, respectively. The overall survival curve for TAC-PR was not inferior to that of TAC-BID.
The TAC-PR protocol was feasible and effective with strict adjustment.
他克莫司是肝移植的关键免疫抑制药物。每日一次的他克莫司缓释制剂（TAC-PR）具有良好的药物依从性，但在肝移植早期难以控制谷浓度。本研究的目的是比较在初发肝移植受者中立即开始口服TAC-PR与传统的每日两次他克莫司（TAC-BID）的可行性和疗效。
本研究纳入了28例接受传统TAC-BID治疗的患者和60例接受TAC-PR治疗的患者（中位随访70.5个月）。比较短期和长期结局。
除肝细胞癌发病率和移植物类型外，患者特征相似。与TAC-BID相比，TAC-PR更频繁地需要调整剂量（73.3%对42.9%，P = 0.006），但两组在肝移植后前3个月的他克莫司谷浓度均得到良好控制。两组的急性细胞排斥率和长期肾功能相似。在两组中，移植后前6个月肾功能恶化，直到随访期结束一直保持稳定。TAC-BID组的1年、3年和5年生存率分别为96.4%、85.7%和85.7%，TAC-PR组分别为96.7%、94.8%和94.8%。TAC-PR的总生存曲线不劣于TAC-BID。
TAC-PR方案在严格调整下是可行且有效的。
